Z-0894-05

IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline...

Name: Z-0894-05 IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline...
Creator: Abbott Health Products, Inc.
Published: 2005-03-24
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2005-03-24 / Terminated / root cause: manufacturing process

FDA source

Abbott Health Products, Inc. began a recall of IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl... on 2005-03-24. The reason FDA records is "Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0894-05
Status: Terminated
Initiated: 2005-03-24
Posted: 2005-06-16
Terminated: 2005-09-29
Recalling firm: Abbott Diagnostic International, Ltd.
Product: IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Abbot Health Products, Inc informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 1-800-777-0051. (US only) Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
Quantity in commerce: 793 kits
Distribution: US Goverment, Domestic and International distribution.
Product codes and lots: 25459Q100

Product code JHI

K912535Class IIImx Total B-HcgAbbott Laboratories / cleared 1991-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)